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- Klinische proef NCT07805811
Testing Heart Failure Resilience Intervention for Caregivers (HEROIC) in Advanced Heart Failure
1 september 2026 bijgewerkt door: Johns Hopkins University
This study will test the mechanisms of a multi-component, nurse-led, primary palliative care intervention, HEart failure Resilience Intervention for Caregivers (HEROIC) to improve caregiver mental well-being, patient health-related quality of life and unplanned acute care in the setting of advanced heart failure.
The investigators will conduct a multi-site, randomized controlled trial to test proposed mechanisms of action in a large sample (N=500) of persons with heart failure and the caregivers.
The investigators will also examine variation in response to HEROIC components by heart failure subgroup (ventricular assist device, heart transplant or medically managed heart failure).
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
Heart failure (HF) is a major source of suffering, the leading cause of death in the US (higher than dementia and cancer combined) and results in $108 billion annually in global health care costs to individuals, families and communities.
Policies limiting reimbursement for HF readmissions increase strain on family caregivers to manage HF in the home with very little support.
Despite advancements in guideline-directed medical therapies, HF patient outcomes are worse than the prior decade - including higher readmissions and mortality.
Increased uptake of advanced HF surgical therapies including durable ventricular assist device and heart transplantation improve patient health-related quality of life (HRQOL) and survival but require high involvement of family caregivers.
The impact of advanced HF care and policy falls on family caregivers who bear increased tasks and responsibilities over time while saving health systems over 7 billion per year.
Caregiving for persons with HF, regardless of advanced therapies, is associated with worsening caregiver mental health, burden, stress, loss of social connections, disruptions to work, and increased financial strain.
The HEart Failure Resilience Intervention for Caregivers (HEROIC) is a theory- and evidence-based primary palliative intervention including 5 individualized nurse-led sessions conducted over 10 weeks via video calls.
HEROIC helps caregivers identify and address caregiving and palliative care needs for the patient, while also focusing on caregiver mental health, leveraging multi-level resilience resources: individual (goal-setting, self-care), community (social support, palliative/clinical, community) and existential (life purpose).
The investigators now propose to conduct a mechanistic randomized controlled trial to test HEROIC mechanisms of action for caregivers (N=250) and persons with advanced HF for whom the caregivers provide care, including those treated medically, or with ventricular assist device or heart transplantation (N=250) in two health systems.
Aim 1 focuses on caregiver self-efficacy and burden as mechanisms of action by which HEROIC improves caregiver mental health at 12 and maintenance at 24 weeks.
Aim 2 focuses on patient mechanisms - increases in HF self-care and reductions in unmet palliative care needs as mediators of improvement in patient HRQOL at 12 and 24 weeks and unplanned acute care at 1 year.
Aim 3 explores differences in mechanisms and response to intervention components by HF subgroup.
The investigators will recruit a Patient and Family Advisory Council to guide the trial and intervention delivery.
An exceptional study team with expertise in intersecting fields of research including HF, caregiving, and mixed methods research will guide the study.
This innovative proposal directly responds to HF guidelines, policy initiatives and National Heart, Lung, and Blood Institute (NHLBI) strategic priorities, including Grant Notice "NOT-HL-23-117" Palliative Care in the Care Continuum, and will provide evidence of a powerful primary palliative care strategy to demonstrate how HEROIC works (mechanisms) so that it can be scaled and adapted across settings and populations.
Studietype
Ingrijpend
Inschrijving (Geschat)
500
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Martha Abshire Saylor, Principal Investigator, PhD, RN
- Telefoonnummer: HEROIC phone number
- E-mail: mabshir1@jhu.edu
Studie Contact Back-up
- Naam: Meagan Clemence, Study Coordinator, M.Ed
Studie Locaties
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Colorado
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Denver, Colorado, Verenigde Staten, 80217
- University of Colorado Anschutz
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Contact:
- Colleen McIlvennan,, PhD, DNP, ANP
- Telefoonnummer: 920-540-0809
- E-mail: Colleen.McIlvennan@cuanschutz.edu
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21205
- Johns Hopkins University, School of Nursing
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Contact:
- Martha Abshire Saylor, PhD
- Telefoonnummer: 443-340-6201
- E-mail: mabshir1@jhu.edu
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Hoofdonderzoeker:
- Martha Abshire Saylor, PhD
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Onderonderzoeker:
- Colleen McIlvennan, PhD, DNP, ANP
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Caregiver Inclusion Criteria:
- English or Spanish-speaking.
- > 18 years old.
- Supports at least one activity of daily living (ADL) or instrumental activity of daily living IADL) for the person with HF (care recipient).
- Lives with the person with HF or visits regularly (e.g. weekly phone calls and visits at least once per month) to provide ADL/IADL support.
- ≥5 on the Zarit Burden Interview
Patient Inclusion Criteria:
- English or Spanish-speaking.
- > 18 years old.
- Reports needing help with at least one activity of daily living or instrumental activity of daily living.
- Identifies a primary caregiver AND caregiver consents.
Diagnosed with heart failure. AND
- If Medically managed, no Ventricular Assist Device (VAD) or Transplant (TX): Documentation of HF with preserved ejection fraction OR HF with reduced ejection fraction (LVEF<40%) OR Documented American College of Cardiology / American Heart Association (ACC/AHA) HF stage C or D (EMR) OR Documentation of New York Heart Association functional class II - IV (EMR)
- If ventricular assist device: > 1 month since implant AND ambulatory/outpatient
- If heart transplant: > 1 month since Heart Transplant (HTx) AND ambulatory/outpatient
Exclusion Criteria:
- Patients and caregivers who screen positive for severe cognitive impairment Telephone Interview for Cognitive Screening (TICS-M) will be excluded.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: HEROIC program
The HEart Failure Resilience Intervention for Caregivers (HEROIC) is a theory- and evidence-based primary palliative care intervention including 5 individualized nurse-led sessions conducted over 10 weeks via video calls.
HEROIC helps caregivers identify and address caregiving and palliative care needs for the patient, while also focusing on caregiver mental health, leveraging multi-level resilience resources: individual (goal-setting, self-care), community (social support, palliative/clinical, community) and existential (life purpose).
|
The HEart Failure Resilience Intervention for Caregivers (HEROIC) is a theory- and evidence-based primary palliative care intervention including 5 individualized nurse-led sessions conducted over 10 weeks via video calls.
HEROIC helps caregivers identify and address caregiving and palliative care needs for the patient, while also focusing on caregiver mental health, leveraging multi-level resilience resources: individual (goal-setting, self-care), community (social support, palliative/clinical, community) and existential (life purpose).
Andere namen:
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Actieve vergelijker: Control condition
The control group will receive written educational materials related to Heart Failure (HF) management, home safety tips, and supportive resources.
This control is selected to provide a comparative baseline that reflects typical care practices without the active intervention elements .
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The control group will receive:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36)
Tijdsspanne: 12 weeks
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Short Form Health Survey (SF-36), mental health composite score.
The mental health composite score is an average of 4 out of 8 sub-scales.
Scoring is 0 to 100, where higher scores indicate better mental health and fewer psychological distress symptoms.
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12 weeks
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Health-related quality of Life (patient) as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Tijdsspanne: 12 weeks
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Kansas City Cardiomyopathy Questionnaire (KCCQ), 12 item version.
Scoring is from 0 to 100 where higher scores indicate better health-related quality of life.
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12 weeks
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Number of unplanned acute care (patient) visits
Tijdsspanne: 1 year
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number of unplanned hospitalization, emergency room visit, urgent care and unscheduled/same-day visits
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1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Caregiver burden as assessed by Zarit Burden Interview
Tijdsspanne: 12 weeks
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Zarit Burden Interview, 13 item version.
Scores range from 0-48 with higher scores indicating worse burden.
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12 weeks
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Self-efficacy (caregiver) assessed by Coping Self-Efficacy Scale (CSE)
Tijdsspanne: 12 weeks
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Coping Self-efficacy.
13 items.
Scores range from 0-130 with higher scores indicating better self-efficacy.
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12 weeks
|
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Self-care (patient) as assessed by the Heart Failure Self-Care Index
Tijdsspanne: 12 weeks
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Heart Failure Self-Care Index, version 8.0, 23 items.
The Heart Failure Self-Care Index uses three separate subscales scored and standardized on a 0 to 100 scale, where 70 or higher indicates adequate self-care.
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12 weeks
|
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Palliative Care Needs as assessed by the Integrated Palliative Outcomes Scale (iPOS)
Tijdsspanne: 12 weeks
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Integrated Palliative Outcomes Scale (iPOS), 10 items.
Scores range from 0-40 with higher scores indicating higher unmet needs.
|
12 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Martha Abshire Saylor, PhD, RN, Johns Hopkins University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Abshire Saylor M, Pavlovic NV, DeGroot L, Jajodia A, Hladek MD, Perrin N, Wolff J, Davidson PM, Szanton S. Strengths-building through life purpose, self-care goal setting and social support: Study protocol for Caregiver Support. Contemp Clin Trials Commun. 2022 May 5;28:100917. doi: 10.1016/j.conctc.2022.100917. eCollection 2022 Aug.
- Abshire Saylor M, Clair CA, Curriero S, DeGroot L, Nelson K, Pavlovic N, Taylor J, Gallo JJ, Szanton S. Analysis of action planning, achievement and life purpose statements in an intervention to support caregivers of persons with heart failure. Heart Lung. 2023 Sep-Oct;61:8-15. doi: 10.1016/j.hrtlng.2023.04.002. Epub 2023 Apr 12.
- Abshire Saylor M, Pavlovic N, DeGroot L, Peeler A, Nelson KE, Perrin N, Gilotra NA, Wolff JL, Davidson PM, Szanton SL. Feasibility of a Multi-Component Strengths-Building Intervention for Caregivers of Persons With Heart Failure. J Appl Gerontol. 2023 Dec;42(12):2371-2382. doi: 10.1177/07334648231191595. Epub 2023 Sep 14.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
4 januari 2027
Primaire voltooiing (Geschat)
30 november 2030
Studie voltooiing (Geschat)
31 maart 2031
Studieregistratiedata
Eerst ingediend
1 september 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 september 2026
Eerst geplaatst (Werkelijk)
4 september 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 september 2026
Laatste update ingediend die voldeed aan QC-criteria
1 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00568390
- 1R01HL183346 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
The scientific data and metadata generated by this project will be archived in a publicly accessible repository that meets recognized standards for data sharing and preservation.
The investigators will deposit the data and metadata in open Inter-university Consortium for Political and Social Research (ICPSR) data repository.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .